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Inclusion criteria included: adult patients (age>18) with unresectable Malignant Pleural Mesothelioma (MPM) who had progressed after one or more prior systemic therapies, had not received prior systemic therapy due to poor performance status (PS), and/or were unwilling to receive systemic chemotherapy.

Pre-assignment Details

The primary objective of this study was to evaluate the anti-tumor activity of zoledronic acid (Zometa) in subjects with unresectable, advanced Malignant Pleural Mesothelioma (MPM).

Arm/Group Title

Zoledronic Acid (Zometa)

Arm/Group Description

Zoledronic acid (Zometa) will be ad...

Arm/Group Description

Zoledronic acid (Zometa) will be administered by infusion on Day 1 of a 3-week cycle followed by tumor assessment from CT and/or PET scans every 2 cycles. This will continue until progression of disease and/or intolerable toxicity.

Zoledronic acid (Zometa) will be administered IV on the first day of a 21 day cycle at a concentration of 4 mg. The treatment will take about 30-60 minutes with the infusion lasting about 15 minutes.

Zometa (zoledronic acid) 4mg will be administered by infusion on Day 1 of a 3-week cycle followed by tumor assessment from CT and/or PET scans every 2 cycles. This will continue until progression of disease and/or intolerable toxicity.

The modified Response Evaluation Criteria in Solid Tumors Criteria (RECIST 2004) will be used for target lesions and assessed by CT scans. Complete Response (CR) is the disappearance of target lesions; Partial Response (PR) is greater than or equal to 30% reduction in the total tumor measurement; Stable Disease (SD) is the absence of response or progression; and Progressive Disease (PD) is a 20% increase in the total tumor measurement over nadir value or the appearance of new lesions.

Time Frame

Baseline up to 28 months or until progressive disease or death

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

Participants with advanced malignant pleural mesothelioma.

Arm/Group Title

Zometa

Arm/Group Description:

Zometa (zoledronic acid) will be ad...

Arm/Group Description:

Zometa (zoledronic acid) will be administered by infusion on Day 1 of a 3-week cycle followed by tumor assessment from CT and/or PET scans every 2 cycles. This will continue until progression of disease and/or intolerable toxicity.

Zometa: Zoledronic acid will be administered IV on the first day of a 21 day cycle at a concentration of 4 mg. The treatment will take about 30-60 minutes with the infusion lasting about 15 minutes.

Overall Number of Participants Analyzed

8

Measure Type: Number

Unit of Measure: percentage of responders

12.5

2.Secondary Outcome

Title

Progression Free Survival (PFS)

Description

Progression Free Survival is defined as the number of days from the da...

Description

Progression Free Survival is defined as the number of days from the day the subject started treatment to the day the subject experienced evidence of disease progression, as determined by radiological or clinical progression.

Time Frame

Baseline up to 28 months

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

Participants with advanced malignant pleural mesothelioma.

Arm/Group Title

Zometa

Arm/Group Description:

Zometa (zoledronic acid) will be ad...

Arm/Group Description:

Zometa (zoledronic acid) will be administered by infusion on Day 1 of a 3-week cycle followed by tumor assessment from CT and/or PET scans every 2 cycles. This will continue until progression of disease and/or intolerable toxicity.

Zometa: Zoledronic acid will be administered IV on the first day of a 21 day cycle at a concentration of 4 mg. The treatment will take about 30-60 minutes with the infusion lasting about 15 minutes.

Overall Number of Participants Analyzed

8

Median (Full Range)

Unit of Measure: Months

2

(0.5 to 21)

3.Secondary Outcome

Title

Overall Survival (OS)

Description

Overall Survival is defined as the number of days from the day the sub...

Description

Overall Survival is defined as the number of days from the day the subject started treatment to the day the subject experienced death or lost to follow-up.

Time Frame

Baseline up to 28 months

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

Participants with advanced malignant pleural mesothelioma.

Arm/Group Title

Zometa

Arm/Group Description:

Zometa (zoledronic acid) will be ad...

Arm/Group Description:

Zometa (zoledronic acid) will be administered by infusion on Day 1 of a 3-week cycle followed by tumor assessment from CT and/or PET scans every 2 cycles. This will continue until progression of disease and/or intolerable toxicity.

Zometa: Zoledronic acid will be administered IV on the first day of a 21 day cycle at a concentration of 4 mg. The treatment will take about 30-60 minutes with the infusion lasting about 15 minutes.

Subjects with either stable disease or objective response continued treatment until disease progression and/or intolerable toxicity at which patients were taken off study. Subjects were monitored for toxicity using NCI CTAE v3.0 Criteria. Dose adjustment was allowed per standard guidelines for zoledronic acid for decreased creatinine clearance. Patients who completed at least one treatment cycle were included in data analysis.

Arm/Group Title

Zoledronic Acid (Zometa)

Arm/Group Description

Zoledronic acid (Zometa) will be ad...

Arm/Group Description

Zoledronic acid (Zometa) will be administered IV-4mg by infusion on Day 1 of a 3-week cycle followed by tumor assessment from CT and/or PET scans every 2 cycles.The treatment will take about 30-60 minutes with the infusion lasting about 15 minutes.This will continue until progression of disease and/or intolerable toxicity.

All-Cause Mortality

Zoledronic Acid (Zometa)

Affected / at Risk (%)

Total

0/8 (0.00%)

Serious Adverse Events Serious Adverse Events

Zoledronic Acid (Zometa)

Affected / at Risk (%)

Total

0/8 (0.00%)

Other (Not Including Serious) Adverse Events Other (Not Including Serious) Adverse Events